Global Lead, Medical Affairs, Gastroenterology (m/f/d)

Global Lead, Medical Affairs, Gastroenterology (m/f/d)

Provide expert medical and clinical insights to inform the effective development of the Gastroenterology medical strategy through internal and external engagements while providing continuous input to ensure that the strategy remains clearly defined and consistent with business objectives.

This GLMAG is an applied medicine subject matter expert within the Gastroenterology therapeutic area responsible for providing medical practice insights, intended use, and anticipated clinical impact. This spans the product lifecycle through all phases of product development and will include internal as well as external scientific HCP (peer-to-peer) as well as societal engagement.

To support the Global Head of Clinical Affairs in the conception, development, and implementation of impactful clinical investigations to arrive at relevant study designs by providing applied medicine therapeutic expertise to the clinical team (e.g., practice insights, care delivery, clinical impact assessments, and intended therapeutic benefit).

The GLMAG will support the Clinical Evaluation team through consultations on literature search strategy, data appraisal, threshold of performance, and assessment of clinical benefits. Contributing authorship of Clinical Evaluation Plan (CEP), Clinical Evaluation Reports (CER), Summary of Safety & Clinical Performance (SSCP) and Periodic Safety Update Report (PSUR) is expected as well as providing input on equivalent comparators, state of the art, to substantiate safety and performance.

Demonstrate proficiencies in understanding and facilitating the coordination of patient care, (including care redesign), across conditions, providers, settings, and time to achieve care that is safe, timely, effective, efficient, equitable, and patient-centric.

The GLMAG will support health economic outcomes research for market access (coverage, coding, reimbursement) by aligning MSA HEMA resources in the most appropriately manner.

Support the Gastroenterology business strategic goals by providing critical insights obtained through productive peer-to-peer physician and societal scientific engagements.

Provide critical input for the patient care pathway, as well as the Scientific Communication Strategy and Publication Strategy. Responsibilities also include supporting responses to Medical Information Requests (MIRs).

Responsible for advocating the Gastroenterology business’ unique needs to be incorporated into the MSA strategy as well as operationally through infrastructure advancements, SOPs, best practices, trainings, and work instructions over a 3–5-year time horizon.

Engage with cross-functional team members in Medical Safety and Infection Prevention Control to provide DU expertise pertaining to risk management, design controls, health hazard assessments, complaints assessment, CAPAs, nonconformances, and benefit risk determinations.

Serve as a member of the GI Business leadership team to provide input on state of the art within the therapeutic space as well as medical affairs strategy for scientific engagement. Support to the Medical & Scientific Affairs subfunctions in their interactions with the Gastroenterology global team is expected.

Collaborate effectively with the growing community of partners including Legal, Finance, Data Privacy, Product Security, IT-Cybersecurity, Intellectual Property, HR, Health Care Compliance, Procurement, and Supply Chain.

Fulfil the role as the medical expert within the Gastroenterology business to provide clinical practice insights to support and assist the team responsible for the review of promotional materials. When necessary incorporate new medical insights to adapt and evolve these materials to regional and global ever changing practice patterns.

Provide medical/scientific input into Business Development, R&D, marketing, and greater Gastroenterology business strategies, based on their knowledge and medical expertise. Guide teams to understand what is medically important in digital product design, development, and lifecycle management. Provide integration strategy and operational implementation guidance for acquisitions.

Minimum Requirements

• Medical Doctor (MD) degree, with demonstrated independent clinical practice experience.
• Gastroenterology Fellowship Trained.
• Board Certification.
• Additional advanced degrees: PhD, MS, MBA, or MPH desired.
• Active participation in a Maintenance of Certification (MOC) program.
• Active medical license.
• 10-12+ years of biotechnology/pharmaceutical/medical device industry experience in medical affairs, medical technology, medical strategy with experience in all phases for development projects and regulatory space or combination of relevant clinical practice, training, and education.
• Deep knowledge of the Gastroenterology therapeutic area and global understanding of medical affairs, clinical evidence development and global healthcare delivery systems.
• Success in product support and ability to bring strategic insight to commercialization plans in respective therapeutic area.
• A track record of executing medical and/or scientific plans in support of product differentiation, addressing healthcare stakeholder needs, and clinical practice patterns on a global level.
• Ability to understand current evolving environmental and market access issues.
• Success working in a matrixed organization, partnering with multiple internal & external stakeholders to deliver against the business unit strategy.
• Ability to think strategically, critically assess and synthesize complicated data and scientific information.
• Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration.
• Experience working in a global cross-functional team (functional/matrix) environment and knowledge and/or experience working with groups with varied cultural backgrounds and learning styles is required.
• Leadership capabilities focused on hiring, nurturing, and retaining a diverse, world-class team of business professionals.
• Excellent written and verbal communication skills in English, including the ability to communicate effectively at all levels of the organization.
• Vitality and scheduling flexibility to commit to a global schedule navigating multiple time zones with extended hours into the early morning as well as late evenings (e.g., Eastern Standard Time: UTC-5, Central European Time: UTC+1, and Japan Standard Time: UTC+9).

Interview Competencies

The interview will be competence based and the following competencies will be assessed:

• Build for the Future
• Deliver Results
• Lead People
• Lead Self
• Model and champion Our Core Values

Benefits

• Flexible working hours, remote work possible (up to 60%).
• 30 days of holidays per year (Germany).
• Modern office and an inspiring working environment (Hamburg).
• Employee restaurant with live cooking and healthy food (subsidized) (Hamburg).
• Public transport ticket (100% subsidized) or free parking space (Hamburg).
• Company sport groups and an inhouse company gym (Hamburg).
• Employee Assistance Program to support your health, mental and emotional well-being (Germany).
• A comprehensive company pension scheme (Germany).
• Company medical officer and vaccination offers (Germany).
• Childcare through our ‘Buttje&Deern’ partner (Hamburg).
• Bike leasing (Germany).

About Olympus Medical Systems

Olympus is passionate about creating customer-driven solutions for the medical, life sciences, and industrial equipment industries. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping to detect, prevent, and treat disease; furthering scientific research; and ensuring public safety.

As a leading medical technology company, our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients and their safety. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications.